Table 4.
P-values and confidence intervals for change from baseline analysis of efficacy endpoints.
| Parameters/ day | G1 | G2 | G1 | G2 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| p-value | 95%CI | p-value | 95%CI | p-value | 95%CI | p-value | 95%CI | |||
| Exercise intolerance | 7 | <0.0001 | −1.5 to −0.5 | <0.0001 | −1 to 0 | VHS | 0.24 | 0.1780 to 0.7486 | 0.401 | 0.01479 to 0.5985 |
| 14 | <0.0001 | −1 to 0 | <0.0001 | −1.5 to −0.5 | 0.051 | 0.4331 to 1.1402 | 0.19 | 0.1768 to 0.7032 | ||
| 28 | <0.0001 | −1 to 0 | <0.0001 | −1.5 to −0.5 | 0.39 | 0.2089 to 0.9911 | 0.75 | 0.1136 to 0.6731 | ||
| 56 | <0.0001 | −1 to 0 | <0.0001 | −1 to 0 | 0.1542 | 0.6383 to 1.5683 | 0.6644 | −0.4522 to 0.6989 | ||
| Appetite | 7 | <0.0001 | −1 to 0 | <0.0001 | −1 to 0 | Lung field | 0.0041 | 0.1607 to 0.7726 | 0.0029 | 0.09872 to 0.4346 |
| 14 | <0.0001 | −1 to 0 | <0.0001 | −1 to 0 | 0.0014 | 0.2519 to 0.9481 | 0.0529 | 0.1297 to 0.6703 | ||
| 28 | <0.0001 | −1 to 0 | <0.0001 | −1 to 0 | 0.0027 | 0.2253 to 0.9747 | 0.0137 | 0.08105 to 0.6523 | ||
| 56 | 0.0663 | 0 to 1 | 0.061 | 0 to 1 | 0.0024 | 0.2174 to 0.9159 | 0.0137 | 0.08105 to 0.6523 | ||
| Respiratory effort | 7 | <0.0001 | −1.5 to −0.5 | <0.0001 | −1.5 to −0.5 | LA/Ao | 0.19 | −0.03493 to 0.1683 | 0.1963 | −0.02914 to 0.1358 |
| 14 | <0.0001 | −1 to 0 | <0.0001 | −1.5 to −0.5 | <0.0001 | −0.4882 to −0.2398 | 0.0597 | −0.003213 to 0.1499 | ||
| 28 | <0.0001 | −1 to 0 | <0.0001 | −1.5 to −0.5 | <0.0001 | −0.4759 to −0.2921 | 0.0001 | −0.4050 to −0.1503 | ||
| 56 | <0.0001 | −1.5 to −0.5 | <0.0001 | −1 to 0 | <0.0001 | −0.5228 to −0.2252 | <0.0001 | −0.4050 to −0.1503 | ||
| Coughing | 7 | <0.0001 | −1.5 to −0.5 | <0.0001 | −1.5 to −0.5 | LVIDd/Ao | 0.0002 | −0.2668 to −0.09252 | <0.0001 | −0.4010 to −0.2003 |
| 14 | <0.0001 | −1 to 0 | <0.0001 | −1.5 to −0.5 | 0.0004 | −0.2770 to −0.08896 | <0.0001 | −0.3953 to −0.1927 | ||
| 28 | <0.0001 | −1.5 to −0.5 | <0.0001 | −1.5 to −0.5 | <0.0001 | −0.4268 to −0.1792 | <0.0001 | −0.3722 to −0.1691 | ||
| 56 | <0.0001 | −1 to 0 | <0.0001 | −1 to 0 | 0.0007 | −0.4099 to −0.1228 | 0.0042 | −0.3492 to −0.07209 | ||
| BUN | 7 | 0.4157 | −19.0646 to 8.0980 | 0.8271 | −13.0205 to 10.4872 | MVE | <0.0001 | −0.3179 to −0.1921 | <0.0001 | −0.2592 to −0.1141 |
| 14 | 0.9904 | −10.2226 to 10.1026 | 0.3875 | −26.2170 to 10.4770 | <0.0001 | −0.4004 to −0.2096 | <0.0001 | −0.3342 to −0.1658 | ||
| 28 | 0.3452 | −2.6095 to 0.9429 | 0.5914 | −3.8304 to 2.2238 | <0.0001 | −0.3456 to −0.1911 | <0.0001 | −0.3110 to −0.1490 | ||
| 56 | 0.8725 | −13.4928 to 11.5128 | 0.1836 | −5.8033 to 1.1633 | <0.0001 | −0.4004 to −0.2096 | <0.0001 | −0.3071 to −0.1262 | ||
| CRE | 7 | 0.2015 | −0.05522 to 0.4352 | 0.2621 | −0.9085 to 0.2551 | cPL | 0.5546 | −81.643 to 121.643 | 0.3964 | −54.6556 to 22.2756 |
| 14 | 0.1123 | −0.2998 to 0.03318 | 0.1402 | −0.08825 to 0.1882 | 0.7884 | −84.383 to 100.903 | 0.098 | −63.0544 to 5.6344 | ||
| 28 | 0.7868 | −0.02164 to 0.02830 | 0.5803 | −0.06210 to 0.03544 | 0.3559 | −12.334 to 6.514 | 0.4459 | −34.0127 to 15.3594 | ||
| 56 | 0.4788 | −0.3465 to 0.1665 | 0.2368 | −0.9157 to 0.2357 | 0.9233 | −154.728 to 145.141 | 0.8593 | −27.8904 to 23.4037 | ||
| ALP | 7 | 0.8036 | −38.7320 to 30.2654 | 0.7137 | −21.6989 to 31.2989 | SDMA | 0.08393 | −0.9105 to 5.5557 | 0.9071 | −4.4106 to 3.9306 |
| 14 | 0.3775 | −60.2883 to 154.3550 | 0.3211 | −19.9996 to 58.9863 | 0.1012 | −0.4737 to 6.2866 | 0.7879 | −4.6641 to 3.5707 | ||
| 28 | 0.3521 | −1.4337 to 3.9003 | 0.3869 | −6.1105 to 15.3105 | 0.0805 | −0.3216 to 3.4183 | 0.9578 | −3.7361 to 3.9361 | ||
| 56 | 0.5819 | −60.3084 to 105.4418 | 0.2539 | −12.8479 to 46.7946 | 0.1528 | −0.7460 to 12.2944 | 0.9986 | −3.7246 to 3.7313 | ||
| ALT | 7 | 0.5063 | −59.3800 to 29.9800 | 0.3087 | −9.2190 to 28.1523 | NT-proBNP | <0.0001 | −2768.3119 to −1731.6881 | <0.0001 | −2478.1855 to −1221.8145 |
| 14 | 0.2365 | −10.1049 to 39.3049 | 0.5667 | −16.8616 to 30.1949 | <0.0001 | −4754.8169 to −3245.1831 | <0.0001 | −4919.8475 to −3513.4859 | ||
| 28 | 0.2458 | −2.1796 to 8.1796 | 0.9319 | −9.0895 to 9.8895 | <0.0001 | −3757.2564 | <0.0001 | −4944.1512 to −3655.8488 | ||
| 56 | 0.8139 | −28.6689 to 36.2022 | 0.9026 | −9.5967 to 10.8301 | <0.0001 | −5237.6909 to −4028.9757 | <0.0001 | −4825.2314 to −3641.4353 | ||
| Na | 7 | 0.1393 | −0.4950 to 3.3616 | 0.0984 | −0.2571 to 2.8571 | Cl | 0.1797 | −0.7313 to 3.7313 | 0.5653 | −1.2077 to 2.1677 |
| 14 | 0.3068 | −3.4603 to 1.1270 | 0.8082 | −1.7148 to 2.1815 | 0.9591 | −2.7051 to 2.5718 | 0.6555 | −1.2381 to 1.9381 | ||
| 28 | 0.2458 | −0.5453 to 0.1453 | 0.5897 | −2.3754 to 1.3754 | 0.2187 | −0.2716 to 1.1383 | 0.4773 | −0.9202 to 1.9202 | ||
| 56 | 0.1561 | 0.7550 to 4.4883 | 0.8484 | −5.2206 to 4.3206 | 0.2929 | −1.1215 to 3.5882 | 0.8604 | −4.4260 to 3.7194 | ||
| K | 7 | 0.2817 | −0.2674 to 0.08069 | 0.5411 | −0.2010 to 0.1077 | P | 0.0691 | −0.04831 to 1.2083 | 0.8926 | −1.0676 to 0.9343 |
| 14 | 0.92 | −0.2824 to 0.2557 | 0.1448 | −0.06447 to 0.4178 | 0.0698 | −0.03920 to 0.9459 | 0.8697 | −1.0241 to 0.8708 | ||
| 28 | 0.8797 | −0.08264 to 0.09597 | 0.2077 | −0.05088 to 0.2242 | 0.1925 | −0.08347 to 0.3968 | 0.923 | −0.2197 to 0.1997 | ||
| 56 | 0.6825 | −0.2776 to 0.1843 | 0.9755 | −0.2234 to 0.2167 | 0.0555 | 0.01305 to 1.1936 | 0.9391 | −0.3674 to 0.3407 | ||